Accessory devices for use with catheters

ABSTRACT

An accessory device may be used in combination with a thrombectomy catheter. The accessory device may be configured to deflect a distal portion of the thrombectomy catheter and/or disrupt a lesion in a vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application a continuation of U.S. Application Serial No.17/094,679, filed Nov. 10, 2020; now U.S. Pat. No. 11,553,942; which isa continuation of U.S. Application No. 15/449,301, filed Mar. 3, 2017,now U.S. Pat. No. 10,828,061; which claims the benefit of priority under35 U.S.C. §119(e) of U.S. Provisional Application No. 62/396,803, filedSep. 19, 2016 and U.S. Provisional Application No. 62/303,193, filedMar. 3, 2016, the entire disclosures of which are herein incorporated byreference.

TECHNICAL FIELD

The disclosure is directed to accessory devices for use with catheters.More particularly, the disclosure is directed to devices to aid inremoving or accelerating the removal of thrombus.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, intravascular use. Some of these devicesinclude guidewires, catheters, and the like. These devices aremanufactured by any one of a variety of different manufacturing methodsand may be used according to any one of a variety of methods. Of theknown medical devices and methods, each has certain advantages anddisadvantages. There is an ongoing need to provide alternative medicaldevices as well as alternative methods for manufacturing and usingmedical devices.

SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices.

In a first example a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the proximal portionand the distal portion, a high pressure tube extending through thecatheter lumen from the catheter proximal portion toward the catheterdistal portion, the high pressure tube configured for communication witha fluid source near the catheter proximal portion, a fluid jet emanatorin communication with the high pressure tube, the fluid jet emanatorhaving at least one jet orifice for directing at least one fluid jetfrom said fluid jet emanator through the catheter lumen, an outfloworifice located along a catheter perimeter of the catheter distalportion, an entrainment inflow orifice positioned along the catheterdistal portion, and an accessory device disposed within the catheterlumen.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may comprise a guidewire having proximalend portion and a distal end portion.

Alternatively or additionally to any of the examples above, in anotherexample, the proximal portion of the guidewire may extend along alongitudinal axis and the distal portion of the guidewire may beconfigured to extend at an angle to the longitudinal axis.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 10 to 50°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 15 to 35°.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may comprise a bent portion disposed between theproximal end portion and the distal end portion of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the bent portion of the guidewire may be configured to deflecta portion of the catheter tube positioned distal to the bent portion.

Alternatively or additionally to any of the examples above, in anotherexample, when the bent portion is positioned at a first longitudinallocation within the catheter lumen, the thrombectomy catheter may have afirst sweep coverage and when the bent portion is positioned at a secondlongitudinal location within the catheter lumen, the second locationproximal to the first location, the thrombectomy catheter may have asecond sweep coverage greater than the first sweep coverage.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise a control handlereleasably secured adjacent to a proximal end of the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may comprise a body portion, a slideportion, and a collet portion.

Alternatively or additionally to any of the examples above, in anotherexample, the collet portion may be configured to be releasably securedto the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may be configured to rotate independent ofthe catheter body.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be configured to rotate with rotationof the control handle.

Alternatively or additionally to any of the examples above, in anotherexample, the bent portion may have a radius of curvature in the range of1 to 2 millimeters.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may have a stiffness that is less than astiffness of the catheter proximal portion and greater than a stiffnessof the catheter distal portion.

In another example, a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion, and an accessory device disposed within thecatheter lumen.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may comprise a guidewire having proximalend portion and a distal end portion.

Alternatively or additionally to any of the examples above, in anotherexample, the proximal portion of the guidewire may extend along alongitudinal axis and the distal portion of the guidewire may beconfigured to extend at an angle to the longitudinal axis.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 10 to 50°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 15 to 35°.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may comprise a bent portion disposed between theproximal end portion and the distal end portion of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the bent portion of the guidewire may be configured to deflecta portion of the catheter tube positioned distal to the bent portion.

Alternatively or additionally to any of the examples above, in anotherexample, when the bent portion is positioned at a first longitudinallocation within the catheter lumen, the thrombectomy catheter may have afirst sweep coverage and when the bent portion is positioned at a secondlongitudinal location within the catheter lumen, the second locationproximal to the first location, the thrombectomy catheter may have asecond sweep coverage greater than the first sweep coverage.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise a control handlereleasably secured adjacent to a proximal end of the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may comprise a body portion, a slideportion, and a collet portion.

Alternatively or additionally to any of the examples above, in anotherexample, the collet portion may be configured to be releasably securedto the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may be configured to rotate independent ofthe catheter body.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be configured to rotate with rotationof the control handle.

In another example, a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion, a guidewire slidably and rotatably disposedwithin the catheter lumen, the guidewire comprising a proximal portion,a distal portion, and a bent portion positioned between the proximal anddistal portions, and a handle releasably secured to the guidewireadjacent to a distal end of the guidewire. The distal portion of theguidewire may extend at an angle relative to a longitudinal axis of theproximal portion of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 10 to 50°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 15 to 35°.

Alternatively or additionally to any of the examples above, in anotherexample, the bent portion of the guidewire may be configured to deflecta portion of the catheter tube positioned distal to the bent portion.

Alternatively or additionally to any of the examples above, in anotherexample, when the bent portion is positioned at a first longitudinallocation within the catheter lumen, the thrombectomy catheter may have afirst sweep coverage and when the bent portion is positioned at a secondlongitudinal location within the catheter lumen, the second locationproximal to the first location, the thrombectomy catheter may have asecond sweep coverage greater than the first sweep coverage.

In another example, a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion, a guidewire slidably and rotatably disposedwithin the catheter lumen, the guidewire comprising a proximal portion,a distal portion, and a bent portion positioned between the proximal anddistal portions, and a handle releasably secured to the guidewireadjacent to a distal end of the guidewire. The distal portion of theguidewire may extend at an angle relative to a longitudinal axis of theproximal portion of the guidewire and the guidewire may have a stiffnessthat is less than a stiffness of the catheter proximal portion andgreater than a stiffness of the catheter distal portion.

Alternatively or additionally to any of the examples above, in anotherexample, the bent portion may have a radius of curvature in the range of1 to 2 millimeters.

In another example, a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion, and an accessory device disposed within thecatheter lumen.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may comprise a guidewire having a proximalend region and a distal end region and an expandable cage affixedadjacent to the distal end region of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may comprise a plurality of strutsextending from a proximal end of the cage to a distal end of the cage.

Alternatively or additionally to any of the examples above, in anotherexample, each strut of the plurality of struts may be formed from two ormore wires.

Alternatively or additionally to any of the examples above, in anotherexample, a proximal end of each strut of the plurality of struts may becoupled to the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration and an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the struts may be configured tocurve away from a longitudinal axis of the guidewire along a length ofthe struts such that a cross-sectional diameter of the cage in theexpanded configuration is larger than a cross-sectional diameter of thecage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strut of the plurality ofstruts may have a generally helically shape such that a distal end ofeach strut is circumferentially offset from a proximal end of saidstrut.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise a control handlereleasably coupled adjacent to a proximal end region of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may be configured to move longitudinallyand/or rotationally independent of the catheter tube.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be configured to move with movement ofthe control handle

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may further comprise a bent portion disposedbetween the proximal end region and the distal end region and theproximal end region of the guidewire wire may extend along alongitudinal axis and the distal end region of the core wire may extendfrom the bent portion at an angle to the proximal end region.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may be configured to deflect the catheter distalportion from a longitudinal axis of the catheter proximal portion.

Alternatively or additionally to any of the examples above, in anotherexample, an amount of deflection of the catheter distal portion varieswith a longitudinal location of the bent portion of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the plurality of struts may comprise in the range of two totwenty struts.

In another example, a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion and an accessory device disposed within thecatheter lumen.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may comprise a guidewire having a proximalend region and a distal end region and an expandable cage affixedadjacent to the distal end region of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may comprise a plurality of strutsextending from a proximal end of the cage to a distal end of the cage.

Alternatively or additionally to any of the examples above, in anotherexample, each strut of the plurality of struts may be formed from two ormore wires.

Alternatively or additionally to any of the examples above, in anotherexample, a proximal end of each strut of the plurality of struts may becoupled to the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration and an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the struts may be configured tocurve away from a longitudinal axis of the guidewire along a length ofthe struts such that a cross-sectional diameter of the cage in theexpanded configuration is larger than a cross-sectional diameter of thecage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strut of the plurality ofstruts may have a generally helically shape such that a distal end ofeach strut is circumferentially offset from a proximal end of saidstrut.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise a control handlereleasably coupled adjacent to a proximal end region of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may further comprise a bent portion disposedbetween the proximal end region and the distal end region and theproximal end region of the guidewire wire may extend along alongitudinal axis and the distal end region of the core wire may extendfrom the bent portion at an angle to the proximal end region.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may be configured to deflect the catheter distalportion from a longitudinal axis of the catheter proximal portion.

Alternatively or additionally to any of the examples above, in anotherexample, an amount of deflection of the catheter distal portion varieswith a longitudinal location of the bent portion of the guidewire.

In another example a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion, an accessory device disposed within thecatheter lumen. The accessory device may comprise a guidewire having aproximal end region and a distal end region, an expandable cagecomprising a plurality of struts affixed adjacent to the distal endregion of the guidewire, and a control handle releasably coupledadjacent to a proximal end region of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the plurality of struts may comprise in the range of two totwenty struts.

Alternatively or additionally to any of the examples above, in anotherexample, each strut of the plurality of struts may be formed from two ormore wires.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration and an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the struts may be configured tocurve away from a longitudinal axis of the guidewire along a length ofthe struts such that a cross-sectional diameter of the cage in theexpanded configuration is larger than a cross-sectional diameter of thecage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strut of the plurality ofstruts may have a generally helically shape such that a distal end ofeach strut is circumferentially offset from a proximal end of saidstrut.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire further may comprise a bent portion disposedbetween the proximal end region and the distal end region and theproximal end region of the guidewire wire may extend along alongitudinal axis and the distal end region of the core wire may extendfrom the bent portion at an angle to the proximal end region.

In another example, a thrombectomy catheter may comprise a catheter tubeextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the catheter proximalportion and the catheter distal portion, a high pressure tube extendingthrough the catheter lumen from the catheter proximal portion toward thecatheter distal portion, the high pressure tube configured forcommunication with a fluid source near the catheter proximal portion, afluid jet emanator in communication with the high pressure tube, thefluid jet emanator having at least one jet orifice for directing atleast one fluid jet from said fluid jet emanator through the catheterlumen, an outflow orifice located along a catheter perimeter of thecatheter distal portion, an entrainment inflow orifice positioned alongthe catheter distal portion, and an accessory device disposed within thecatheter lumen. The accessory device may comprise a guidewire having aproximal end region and a distal end region, an expandable cageconfigured to move between a collapsed configuration and an expandedconfiguration, the expandable cage comprising a plurality of strutsaffixed adjacent to the distal end region of the guidewire, and acontrol handle releasably secured adjacent to a proximal end of theguidewire, the control handle and the guidewire configured to movelongitudinally and rotationally independent of the catheter tube. In theexpanded configuration, each strut of the plurality of struts may have agenerally helically shape such that a distal end of each strut iscircumferentially offset from a proximal end of said strut.

The above summary of some example embodiments is not intended todescribe each disclosed embodiment or every implementation of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is an isometric view of a cross stream mechanical thrombectomycatheter with a backloading manifold;

FIG. 2 is an isometric exploded view of the cross stream mechanicalthrombectomy catheter with a backloading manifold;

FIG. 3 is an exploded cross section side view of the components of thecross stream mechanical thrombectomy catheter with a backloadingmanifold;

FIG. 4 is an isometric view of the insert showing an elongated slotextending through the main body;

FIG. 5 is a cross section view of the assembled elements of FIG. 3 ;

FIG. 6 is a cross section view of the cross stream mechanicalthrombectomy catheter with a backloading manifold along line 6-6 of FIG.5 ;

FIG. 7 is a bottom view of the distal end of the cross stream mechanicalthrombectomy catheter with a backloading manifold showing the smoothcatheter tube, the outflow orifice, and the inflow orifice, as well asthe high pressure tube visible through the outflow orifice and theinflow orifice;

FIG. 8 is an exploded isometric view of the fluid jet emanator;

FIG. 9 is an assembled side view in cross section along line 9-9 of FIG.8 of the fluid jet emanator;

FIG. 10 is a side view in cross section illustrating the elements ofFIG. 9 secured in the distal portion of the smooth catheter tube by aradiopaque marker band, as well as showing the cross stream flow;

FIG. 11 is a side view of the distal region of the cross streammechanical thrombectomy catheter with a backloading manifold showing thedistal end of a smooth catheter tube assembly positioned in a bloodvessel (shown in cross section) at a site of a thrombotic deposit orlesion;

FIG. 12 is a side view in cross section illustrating the introduction ofa guidewire into the cross stream mechanical thrombectomy catheter withbackloading manifold;

FIG. 13 is a side view of a distal end region of an illustrativeguidewire and thrombectomy catheter with an illustrative control handlein a first configuration;

FIG. 14 is a side view of distal end region of an illustrative guidewireand thrombectomy catheter with an illustrative control handle in asecond configuration;

FIG. 15 is a schematic side view of a distal end region of anillustrative guidewire having a bend formed therein;

FIGS. 16-20 illustrate an illustrative method for loading a guidewireinto an illustrative catheter;

FIG. 21 is a perspective view of an illustrative accessory device;

FIG. 22 is a side view in partial cross-section illustrating theaccessory device of FIG. 21 with an illustrative catheter in a vessel;

FIG. 23 is a side view of another illustrative accessory device;

FIG. 24 is a side view of another illustrative accessory device;

FIG. 25 is a side view of another illustrative accessory device;

FIG. 26 is a side view of another illustrative accessory device;

FIG. 27 is a side view of another illustrative accessory device;

FIG. 28 is a side view of another illustrative accessory device;

FIG. 29 is a side view of another illustrative accessory device;

FIG. 30 is a side view of another illustrative accessory device;

FIG. 31 is a side view of another illustrative accessory device;

FIG. 32 is a side view of another illustrative accessory device in afirst configuration;

FIG. 33 is another side view of the illustrative accessory device ofFIG. 32 in a second configuration;

FIG. 34 is another side view of the illustrative accessory device ofFIGS. 32 and 33 in a third configuration;

FIG. 35A is a side view of another illustrative accessory device; and

FIG. 35B is an end view of the illustrative accessory device of FIG.35A.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit aspects of the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the term “about” may be indicative asincluding numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

Although some suitable dimensions ranges and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the invention. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment unless clearly stated to the contrary.

Thrombectomy catheters and systems may be used to remove thrombus,plaques, lesions, clots, etc. from veins or arteries. These devices maybe effective to remove acute thrombus but may be less effective on olderor more organized thrombus, or areas of large clot burden such as thatseen in deep vein thrombosis (DVT). It may be desirable to provide athrombectomy catheter with an accessory device to be used in combinationwith the thrombectomy catheter.

FIG. 1 is an isometric view of an enhanced cross stream mechanicalthrombectomy catheter with a backloading manifold 10. Externally visiblemajor components of an embodiment of the present disclosure may includea centrally located backloading manifold 12, a flexible and taperedstrain relief 16 connected to and extending from the backloadingmanifold 12, a catheter tube extending from a proximal portion to adistal portion and composed of a braided catheter tube 18 connected tothe backloading manifold 12 and extending through the tapered andflexible strain relief 16 and a smooth catheter tube assembly 19 havinga smooth catheter tube 20 connected to and extending distally from thebraided catheter tube 18. The components of the smooth catheter tubeassembly 19 are depicted fully in FIGS. 2 and 3 . In some cases, thebraided catheter tube may be formed of a flexible or semi-flexiblematerial, such as but not limited to polyimide or other such suitablecomposition. It is contemplated that the smooth catheter tube 20 may beformed of a plastic composition, although this is not required. In somecases, the catheter tube 18 is formed as a braided construction forstrength, as shown, but it can be effectively formed in other ways: forexample, by using reinforcing components such as fibers, wound strands,rings, wraps, or combinations thereof. Also shown is the junction 118between the smooth catheter tube 20 and the braided catheter tube 18,such junction being suitably effected to provide for a smooth andcontinuous coupling of the smooth catheter tube 20 and the braidedcatheter tube 18.

An outflow orifice 22 and an entrainment inflow orifice 24 may belocated in longitudinal alignment along an imaginary line at the distalportion of the smooth catheter tube 20 near a flexible tapered tip 26located distally at the end of the smooth catheter tube 20. Forillustration purposes, the outflow orifice 22 and the inflow orifice 24,which extend through the smooth catheter tube 20, are shown on the sideof the smooth catheter tube 20, but can be located along any imaginaryline extending longitudinally along a distal surface of the smoothcatheter tube 20, such as is shown in FIGS. 3, 7, 10, and 11 . In someembodiments, the thrombectomy catheter 10 may further include aradiopaque marker band 28 located on the smooth catheter tube 20 inclose proximity to and proximal to the outflow orifice 22, a radiopaquemarker band 30 located on the smooth catheter tube 20 in close proximityto and distal to the inflow orifice 24.

The backloading manifold 12 may further include a central body 34 havinga proximally located cavity body 38. The central body 34 may be coupledto a proximal end of the strain relief 16. A hemostatic nut 14 may bethreadingly secured to the backloading manifold 12. The hemostatic nut14 may include a beveled surface entrance configured to receive anintroducer 15. The introducer 15 may include a centrally located shaft102 with a beveled surface entrance 105, an actuating handle 104, andrings 106 and 108 about the shaft 102.

Other externally visible major components may include, a high pressureconnection branch 32 extending from the central body 34 of thebackloading manifold 12, an exhaust branch 36 extending from thejunction of the central body 34 of the backloading manifold 12 and thehigh pressure connection branch 32, and a high pressure connector 64engaging with and extending from the high pressure connection branch 32of the backloading manifold 12. An orifice 65 located in the highpressure connection branch 32 may allow for the introduction of anadhesive 61 (see, for example, FIG. 5 ) to secure the high pressureconnector 64 in the high pressure connection branch 32. The exhaustbranch 36 may have a threaded surface 63 at its end for attaching tosuction apparatus.

FIG. 2 is an isometric exploded view of the enhanced cross streammechanical thrombectomy catheter with backloading manifold 10, and FIG.3 is an exploded cross section side view of the components of theenhanced cross stream mechanical thrombectomy catheter with abackloading manifold 10.

As described herein, the backloading manifold 12 may include the centralbody 34 which may be tubular and have on one end a proximally locatedcavity body 38 including an externally located threaded surface 40 andon the other end a distally located tubular manifold extension 42,including an orifice 73 which may be utilized to introduce adhesive 43(as shown in FIG. 5 ) to secure the proximal end of the braided cathetertube 18 to the distal manifold cavity 56. A multi-radius insert cavity44 is continuously co-located within the central body 34 and a portionof the adjacent cavity body 38. The multi-radius insert cavity 44 iscomprised of an elongated distal insert cavity portion 46 locatedcoaxially within the central body 34 adjacent to and connecting to aproximal insert cavity portion 48 located coaxial to the cavity body 38in continuous fashion. The insert cavity 44 accommodates an insert 50.The entire insert 50 is accommodated by the insert cavity 44 where thedistal insert cavity portion 46 and the proximal insert cavity portion48 fittingly accommodate separate geometric configurations of the insert50.

A proximal manifold cavity 52 is located coaxially within the cavitybody 38 and is continuous with and proximal to the proximal insertcavity portion 48 and an annular cavity wall 54 and an annular andplanar surface 55 located between the annular cavity wall 54 and theproximal insert cavity portion 48. The manifold extension 42 extendingdistally from the distal end of the backloading manifold 12 includes aninwardly located distal manifold cavity 56 for passage of the proximalend of the braided catheter tube 18. The exterior of the manifoldextension 42 accommodates the strain relief 16. The strain relief 16 isof flexible construction and includes a proximally located strain reliefmounting cavity 58 connected to a passageway 60 both of which extendalong the longitudinal axis of the strain relief 16. The strain reliefmounting cavity 58 accommodates the manifold extension 42, which can beappropriately secured therein, such as by adhesive or mechanicalinterference.

The high pressure connection branch 32 includes a high pressureconnection branch passageway 62 intersecting and communicating with thedistal insert cavity portion 46 of the insert cavity 44, as well asoffering accommodation of the threaded high pressure connector 64. Thethreaded high pressure connector 64 may be configured to be operativelycoupled to a fluid source positioned near the proximal portion of thecatheter 18, 20 to provide communication between the fluid source andthe high pressure tube 71. In some cases, the fluid source may bedirectly coupled to the high pressure connector 64 and in other casesthe fluid source may be indirectly coupled to the high pressureconnector 64. A ferrule 66 having a central bore 70 is accommodated bythe lumen 67 of the high pressure connector 64. One end of a highpressure tube 71 is accommodated by and sealingly secured to the centralbore 70 of the ferrule 66, such as by a weldment or mechanicalinterference. An exhaust branch passageway 72 central to the exhaustbranch 36 communicates with the high pressure connection branchpassageway 62 and with the distal insert cavity portion 46 of the insertcavity 44. The exhaust branch 36 has a threaded surface 63 at its endfor attaching to a suction apparatus. As also shown in the isometricview of FIG. 4 , the insert 50 includes a tubular main body 74 having aproximally located shoulder 76 which can be tapered or of other suitablegeometric configuration. The shoulder 76 engages an annular transitionstop surface 78 (FIG. 3 ) between the proximal insert cavity portion 48and the distal insert cavity portion 46. One end of a central passageway80 truncatingly intersects an elongated slot 82; and such centralpassageway also intersects a bore 84 which is also truncated byintersecting the elongated slot 82, e.g., the central passageway 80adjoins bore 84 and each is truncated by intersection with the elongatedslot 82. The elongated slot 82 extends through the main body 74 tointersect and align to a portion of the longitudinal axis of the insert50. The elongated slot 82 accommodates passage of the high pressure tube71, as shown in FIG. 5 . The central passageway 80 has a proximallylocated beveled surface entrance 86 resembling a cone. The beveledsurface entrance 86 is utilized for guidance and alignment forbackloading of a guidewire through the backloading manifold 12, asdescribed herein.

Beneficial to an embodiment of the present disclosure is the use of aself-sealing hemostatic valve 88, flanking washers 90 and 92, and anintroducer 15 which are related to a patent application entitled“Thrombectomy Catheter Device Having a Self-Sealing Hemostatic Valve,”U.S. Pat. No. 7,226,433, which is herein incorporated by reference. Theself-sealing hemostatic valve 88, which is slightly oversized withrespect to the proximal manifold cavity 52, and the washers 90 and 92are aligned in and housed in the proximal manifold cavity 52 at one endof the backloading manifold 12. The hemostatic nut 14 includes acentrally located cylindrical boss 94, a central passageway 96 having abeveled surface entrance 97 extending through and in part forming thecylindrical boss 94, and internal threads 98. The internal threads 98 ofthe hemostatic nut 14 can be made to engage the threaded surface 40 ofthe backloading manifold 12, whereby the cylindrical boss 94 is broughtto bear against the washer 90 to resultantly bring pressure to bear asrequired against the self-sealing hemostatic valve 88 and washer 92. Thewashers 90 and 92 and the self-sealing hemostatic valve 88 are capturedin the proximal manifold cavity 52 by threaded engagement of thehemostatic nut 14 to the cavity body 38 of the backloading manifold 12.Also included in the hemostatic nut 14 is an annular lip 100 which canbe utilized for snap engagement of particular styles or types ofintroducers, as required, such as introducer 15 provided to aid inaccommodation of a guidewire in either direction and to provide forventing for the interior of the backloading manifold 12. The introducer15 includes a centrally located shaft 102 with a central passageway 103having a beveled surface entrance 105, an actuating handle 104, andrings 106 and 108 about the shaft 102.

Also shown in FIG. 3 is a catheter lumen 110 central to the braidedcatheter tube 18 which joiningly connects to and communicates with alumen 112 central to the smooth catheter tube 20 to form a lumenextending between the catheter proximal portion and the catheter distalportion or, in other words, the proximal portion and the distal portionof the catheter tube. The high pressure tube 71 may extend through thelumen 1110 of the braided catheter tube 18 and the lumen 112 of thesmooth catheter tube 20. A circular support ring 114 is suitablyattached to the high pressure tube 71, such as by a weldment, and islocated within the smooth catheter tube 20 in supporting alignment withthe radiopaque marker band 28. A fluid jet emanator 116 includingterminated loop 117 at and in fluid communication with the distal end ofthe high pressure tube 71 and a circular support ring 124 is locateddistal of the inflow orifice 24 within the distal end of the smoothcatheter tube 20 in alignment with the radiopaque marker band 30, asdescribed in detail with respect to FIG. 10 . The circular support rings114 and 124 together with the respective associated radiopaque markerbands 28 and 30 constitute means for retaining the high pressure tube 71in alignment with the catheter tube composed of braided catheter tube 18and the smooth catheter tube 20.

FIG. 4 is an isometric view of the insert 50 showing the elongated slot82 extending through the main body 74 in intersection with the centralpassageway 80 and the bore 84. The elongated slot 82 is beneficial foraccommodation of the high pressure tube 71, as well as for communicationbetween the combined lumens 110 and 112 of the braided catheter tube 18and the smooth catheter tube 20, respectively, and the high pressureconnection branch passageway 62 and the exhaust branch passageway 72, asshown in FIG. 5 .

FIG. 5 is a cross section view of the assembled elements of FIG. 3 .Particularly shown is the relationship of the high pressure tube 71, theinsert 50, the lumen 110 of the braided catheter tube 18, and theproximal end of the braided catheter tube 18. The proximal portion ofthe high pressure tube 71 extends distally from the ferrule 66 throughthe high pressure connection branch passageway 62, through the elongatedslot 82 of the insert 50 while traversing the distal portion of thecentral passageway 80 en route to and into the lumen 110 of the braidedcatheter tube 18, and thence along the lumen 110 and into the lumen 112of the smooth catheter tube 20 to terminate as part of the fluid jetemanator 116 shown adjacent to the flexible tapered tip 26 at the distalend of the smooth catheter tube 20. In addition to providing a passagefor the high pressure tube 71, the elongated slot 82 allowscommunication between the lumen 110 of the braided catheter tube 18 andthe lumen 112 of the smooth catheter tube 20, collectively, and the highpressure connection branch passageway 62 and the exhaust branchpassageway 72 for evacuation of effluence therefrom. Also shown is thejunction 118 between the smooth catheter tube 20 and the braidedcatheter tube 18, such junction being suitably effected to provide for asmooth and continuous coupling of the smooth catheter tube 20 and thebraided catheter tube 18.

FIG. 6 is a cross section view of the enhanced cross stream mechanicalthrombectomy catheter with backloading manifold 10 along line 6-6 ofFIG. 5 . Shown in particular is the elongated slot 82 through which thehigh pressure tube 71 passes (passage of high pressure tube 71 notshown) and through which communication takes place between the lumen 110of the braided catheter tube 18 and the high pressure connection branchpassageway 62 and the exhaust branch passageway 72. Also shown is alumen 120 central to the high pressure tube 71.

FIG. 7 is a bottom view of the distal end of the enhanced cross streammechanical thrombectomy catheter with backloading manifold 10 showingthe smooth catheter tube 20 and the outflow orifice 22 and the infloworifice 24, as well as the high pressure tube 71 visible through theoutflow orifice 22 and the inflow orifice 24.

FIG. 8 is an exploded isometric view and FIG. 9 is an assembled sideview in cross section along line 9-9 of FIG. 8 of the fluid jet emanator116. The fluid jet emanator 116 includes a terminated loop 117 at thedistal end of the high pressure tube 71 and includes the support ring124. The terminated loop 117 includes a plurality of proximally directedjet orifices 122 a-122 n (collectively, 122). The support ring 124suitably secures to the distal surface of the terminated loop 117 suchas by a weldment. A center void 126 of the terminated loop 117 allowsfor passage of a guidewire or other suitable devices. The support ring124, a tubular device, includes a central passageway 128 correspondingin use to that of the center void 126 of the terminated loop 117 forpassage of a guidewire or other suitable devices. A distally locatedannular shoulder 130 on the support ring 124 allows for the inclusion ofa beveled annular surface 132 juxtaposing the central passageway 128 toaid in the guided accommodation of a guidewire or other suitable deviceat the distal portion of the central passageway 128. A wide annulargroove 134 is formed between the annular shoulder 130 and the distallyfacing surface of the terminated loop 117 and the smaller radiused bodyof the support ring 124. The wide annular groove 134 is utilized tosecure the fluid jet emanator 116 at a suitable location in the distalportion of the smooth catheter tube 20, as shown in FIG. 10 .

The mode of operation of the enhanced cross stream mechanicalthrombectomy catheter with backloading manifold 10 is explained withreference to FIGS. 10, 11, and 12 . FIG. 10 illustrates the elements ofFIG. 9 secured in the distal portion of the smooth catheter tube 20 bythe radiopaque marker band 30 which forces an annular portion of thesmooth catheter tube 20 into the wide annular groove 134 formed by thesupport ring 124 and the terminated loop 117 of the fluid jet emanator116. High velocity fluid jets 136 a-136 n (collectively, 136) are shownemanating proximally from the plurality of jet orifices 122 a-122 n(collectively, 122) into the lumen 112 of the smooth catheter tube 20for subsequent creation of and culminating in cross stream jets 140a-140 n (collectively, 140), as depicted by heavy lines, which flow fromthe outflow orifice 22 and return through the inflow orifice 24 forablative action with thrombus material and for maceration of foreignmaterial in concert with the high velocity fluid jets 136 a-136 n and/orfor exhausting proximally with the flow within the distal portion of thesmooth catheter tube 20. A guidewire 141 is also shown in see-throughdepiction, including alternate guidewire end positions 141 a and 141 bdesignated by dashed lines, where the guidewire 141 extends along thelumen 112 of the smooth catheter tube 20, through the center void 126 ofthe terminated loop 117, and through the central passageway 128 of thesupport ring 124 into the proximal portion of the flexible tapered tip26. Guidewire 141 can be advanced beyond the flexible tapered tip 26 ofthe smooth catheter tube 20 such as during positioning of the catheterwithin the blood vessel or other body cavity, and then withdrawn toalternate guidewire end positions 141 a and 141 b, or other positionswithin the smooth catheter tube 20, or withdrawn completely from thesmooth catheter tube 20. An advantage of an embodiment of the presentdisclosure is that the guidewire 141 can be introduced by a frontloading approach or by a backloading approach and, therefore, can beremoved and reintroduced or can be replaced by a different guidewire.

FIG. 11 is a side view of the distal region of the enhanced cross streammechanical thrombectomy catheter with a backloading manifold 10 showingin particular the distal end of the smooth catheter tube assembly 19positioned in a blood vessel 142 (shown in cross section) at a site of athrombotic deposit or lesion 144. While FIG. 11 depicts the smoothcatheter tube assembly 19 as being in a blood vessel in particular, itis to be understood that it is not limited to use in a blood vessel buthas utility with respect to any body cavity in general. High velocityfluid jets 136 a-136 n (shown in FIG. 10 ) of saline or other suitablesolution are emanated or emitted in a proximal direction from the fluidjet emanator 116 into the smooth catheter tube 20 and pass through theoutflow orifice 22 creating cross stream jets 140 a-140 n directedtoward the wall of the blood vessel 142 having thrombotic deposits orlesions 144 and thence are influenced by the low pressure at the infloworifice 24 to cause the cross stream jets 140 a-140 n to be directeddistally substantially parallel to the central axis of the blood vessel142 to impinge and break up thrombotic deposits or lesions 144 and to,by entrainment, urge and carry along the dislodged and ablatedthrombotic particulates 146 of the thrombotic deposits or lesions 144through the inflow orifice 24, a relatively low pressure region, andinto the lumen 112, which functions as a recycling maceration lumen orchamber and also as an exhaust lumen. The entrainment through the infloworifice 24 is based on entrainment by the high velocity fluid jets 136a-136 n. The outflow is driven by internal pressure which is created bythe high velocity fluid jets 136 a-136 n and the fluid entrained throughthe inflow orifice 24. The enhanced clot removal is enabled because ofthe recirculation pattern established between inflow orifice 24 and theoutflow orifice 22, which creates a flow field that maximizes drag forceon wall-adhered thrombus, and because of impingement of the cross streamjets 140 a-140 n. The cross stream jets 140 a-140 n, whilst beingforcefully directed outwardly and toward the wall of the blood vessel142, by opposite reaction urge the distal portion of the smooth cathetertube 20 in the direction opposite the outward flow direction and awayfrom the impingement area of the cross stream jets 140 a-140 n with theimmediate thrombotic deposit or lesion 144 and/or the wall of the bloodvessel 142, thus distancing the highly concentrated high velocity crossstream jets 140 a-140 n from the immediate thrombotic deposit or lesion144 and/or the wall of the blood vessel 142 and thereby minimizingpotential blood vessel wall damage. The cross stream jets 140 a-140 ntraversing between the outflow orifice 22 and the inflow orifice 24combine to offer an enhanced broad cross section ablation area, sucharea having a breadth substantially larger and having more concentratedforce than prior art devices using multiple inflow and outflow orificeswhere cross streams are of diminished force and breadth. Having aconcentrated flow combining cross stream jets 140 a-140 n offersselective and directed ablation to take place. Prior art devices usingmultiple inflow and outflow orifices and having multiple flow areasgenerate cross streams which are equally weak in all directions, as theflow force is divided between the multiple flow streams, wherebyablation forces cannot be concentrated where desired. The distal end ofthe smooth catheter tube 20 can be rotated axially to direct the crossstream jets 140 a-140 n about a longitudinal axis to have 360° coverageor can be rotated axially to offer coverage partially about thelongitudinal axis, as required.

The placement of the guidewire 141 within or the removal of theguidewire 141 from the enhanced cross stream mechanical thrombectomycatheter with backloading manifold 10 influences the operation of anembodiment of the present disclosure. Suitably strong and well directedablation flow can take place with a guidewire 141 extending the fulllength of the enhanced cross stream mechanical thrombectomy catheterwith backloading manifold 10 and/or additionally extending in a distaldirection beyond the flexible tapered tip 26 and along the vasculature.Such ablation flow can be further improved, enhanced, modified orotherwise influenced by varying the location of or by full removal ofthe guidewire 141. With reference to FIG. 10 , the guidewire 141, asshown, allows suitable transition of the high velocity fluid jets 136a-136 n through the outflow orifice 22 to form cross stream jets 140a-140 n which return via the inflow orifice 24. If, for example, theguidewire 141 is urged proximally to a guidewire end position 141 abetween the inflow orifice 24 and the outflow orifice 22, the infloworifice 24 is totally unrestricted and has less flow resistance, therebyallowing greater and more forceful ingress of the cross stream jets 140a-140 n laden with ablated thrombotic particulates 146, whereas the flowthrough the outflow orifice 22 remains substantially constant. Urgingthe guidewire 141 further in a proximal direction to a guidewire endposition 141 b distal to the outflow orifice 22 causes the outfloworifice 22 and the inflow orifice 24 both to be totally unrestricted andboth to have less flow resistance, thereby allowing greater and moreforceful flow from the outflow orifice 22, as well as resultantlyincreased ingress of the cross stream jets 140 a-140 n laden withablated thrombotic particulates 146 through the inflow orifice 24. Eachof the examples given herein where the guidewire 141 is not totallyremoved from the smooth catheter tube 20 or other proximally locatedregions promotes sustained maceration of the loitering entrained ablatedthrombotic particulates 146 where the smaller ablated thromboticparticulates 146 are exhausted proximally through the smooth cathetertube 20, the braided catheter tube 18, and the associated and pertinentstructure proximal thereto. In another example, urging of the guidewire141 to a position proximal of the proximal end of the braided cathetertube 18 or total removal of the guidewire 141, in addition to allowingtotal unrestricted flow through the outflow orifice 22 and the infloworifice 24, allows unrestricted flow of ablated thrombotic particulates146 along the smooth catheter tube 20, the braided catheter tube 18, andthe associated and pertinent structure proximal thereto.

Although the illustrated cross stream mechanical thrombectomy catheterincorporates an inflow orifice 24 and an outflow orifice 22 aligned tothe high pressure tube 71, one or both of the inflow or outflow orificesmay be located so that they do not align with the high pressure tube; inthis case, other means for guiding a guidewire past the orifice(s) isprovided to prevent the guidewire from inadvertently passing through thenon-aligned orifice(s).

FIG. 12 is a side view in cross section illustrating the introduction ofthe guidewire 141 into the enhanced cross stream mechanical thrombectomycatheter with backloading manifold 10. When it is desired to remove aguidewire, such as guidewire 141, or exchange guidewires havingdifferent attributes, backloading is facilitated by the structure of theinsert 50. Loading can be accomplished, if necessary, using theintroducer 15 to gain entry through the self-sealing hemostatic valve 88where the introducer parts the sealing structure of the self-sealinghemostatic valve 88 to allow entry of the guidewire 141 therethrough.Otherwise the guidewire can pass unaided through the self-sealinghemostatic valve 88. The tip of the guidewire may not be in properalignment with the central passageway 80, such as is shown by theguidewire 141 shown in dashed lines. In such case, impingement of thetip of the distally urged guidewire 141 with the conically-shapedbeveled surface entrance 86 of central passageway 80 directs the tip ofthe guidewire 141 to align with and to be engaged within the centralpassageway 80 of the insert 50 and to be in alignment, as shown, withinthe central passageway 80 so as to align with and be subsequentlyengaged within the proximal portion of the braided catheter tube 18 forpassage therethrough. Distal urging of the guidewire 141 also positionsthe tip of the guidewire 141 for passage through the distal region ofthe smooth catheter tube 20 where the geometry helpfully accommodatessuch passage by and along the outflow orifice 22 and the inflow orifice24 and through the fluid jet emanator 116, the support ring 124, and theflexible tapered tip 26. Preferably, the tip of the guidewire 141 isdome-shaped. Such a dome shape is easily guided by and accommodated bythe proximally-facing rounded surface of the terminated loop 117 of thefluid jet emanator 116. Use of the introducer 15 can also be utilized iffront loading of a guidewire is required for passage through theself-sealing hemostatic valve 88. Preferably, the guidewire 141 exhibitssufficient size, flexibility and other attributes to navigate thetortuous vascular paths, but exhibits sufficient rigidity not to kink,bend or otherwise be permanently deformed and to stay within theappropriate confines of the distal portion of the smooth catheter tube20 and not stray through the outflow orifice 22 or the inflow orifice24. The cross sections of the outflow orifice 22 and the inflow orifice24 are such that entry thereinto of the horizontally aligned guidewireof sufficient size and larger cross section profile is next toimpossible. Notwithstanding, the use of one pair of inflow and outfloworifices further reduces the chance of inadvertent exiting of theguidewire tip through an orifice. This is just one illustrativethrombectomy catheter. Other thrombectomy catheters are described incommonly assigned U.S. Pat. 8,998,843 and 9,078,691, which are hereinincorporated by reference.

As described herein, it may be desirable to provide a thrombectomycatheter with an accessory device to facilitate the removal of olderthrombus, which may be harder than an acute thrombus, or the removal ofareas of large clot burden. It is contemplated that the accessory devicemay be a guidewire based device that may be inserted through a guidewirelumen or aspiration lumen of a thrombectomy catheter. The accessorydevices may be considered tissue disrupters. They may include variouscages, shapes, bumps, unique bends, inverted umbrellas, mixers,blenders, bent guidewires with or without distal cages, deflectors,propellers for mixing, coils, grabbers with fingers, serrated grabbers,offset rotating masses, or combinations thereof. Each of these devicesmay be operated in a pecking motion, dragging motion, and/orrotationally either via a motor or manually. The accessory devices mayhelp aid in the disruption of the clot or maceration which may thenincrease the effective removal when combined with the evacuative andshearing properties of a thrombectomy catheter. The accessory devicesmay also eloquently and simply deflect the catheter tip in a controlledmanner which may increase the diametrical zone of disruption andremoval. Some of the accessory devices may also be configured to centerthe thrombectomy catheter. This may keep the accessory device and/orthrombectomy catheter from riding in the same continual path or upagainst the wall. Riding against the vessel wall especially in aforceful manner may lead to tissue dissection or damage.

In some instances, a guidewire with a predetermined bend placed at aparticular distance from the floppy distal tip may be used incombination with a thrombectomy catheter. The location and degree ofcurvature of this bend may dictate the amount of deflection of thecatheter in which the guidewire resides. The bend location and wiredesign may also dictate the amount or length of floppy wire emanatingfrom the distal tip of the catheter, such as the catheter 10 describedherein. Additionally, a rotatable control handle may be provided at theproximal end of the wire to ergonomically enable the user to rotate thewire to generate a circular sweeping action to gain greater coveragewithin a larger vessel and/or to manipulate the path of the catheter 10.This may help to keep the thrombectomy catheter from riding in the samecontinual path or up against the vessel wall. The handle may also beused to advance or retract the wire to control the placement and/ormagnitude of the diametrical bend of the catheter tip.

A side view of an illustrative rotatable control handle 150 coupled withthe manifold 12 of the illustrative thrombectomy catheter 10 in a firstconfiguration and a second configuration, are illustrated in FIGS. 13and 14 , respectively. The rotatable control handle 150 may have aproximal end 153 and a distal end 151 for connecting the handle 150. Insome instances, the control handle 150 may be connected to the manifold12 through a rotatable Luer connector 152. It is contemplated that therotatable Luer connector 152 may secure the handle 150 to the manifold12 while allowing for rotation of the control handle 150 relative to themanifold 12. While the connector 152 is described as a Luer connector,it is contemplated that any connector that allows the handle 150 torotate relative to the manifold 12 may be used. Such a rotatableconnection may allow the guidewire 162 (or other accessory device) torotate independent of the thrombectomy catheter 10 such that theguidewire 162 may be used to facilitate dislodgment of a thrombus,lesion, plaque, etc. It is contemplated that in some embodiments, thehandle 150 may not rotate relative to the manifold 12. A variety ofcoupling mechanisms may be used to secure the Luer connector 152 to themanifold, including, but not limited to, press fittings, snap fittings,mating threads and grooves, etc. A second Luer connector 154 may couplethe rotatable Luer connector 152 to the handle positioning slide 158.While not explicitly shown, the rotatable Luer connector 152, Luerconnector 154, and handle positioning slide 158 may each include a lumenfor receiving a guidewire 162, or other accessory device, therethrough.The handle positioning slide 158 may be slidably disposed within ahandle body 156 such that the slide 158 and/or the body 156 may sliderelative to one another. For example, FIG. 13 illustrates the handle 150in a first, or fully distally advanced, configuration and FIG. 14illustrates the handle 150 in a second, or fully proximally retractedconfiguration. In some instances, the handle slide 158 and/or the handlebody 156 may include stop features configured to limit the retractionand/or advancement range (e.g., proximal and/or distal movement) of thehandle slide 158 and/or the handle body 156. The handle 150 may furtherinclude a wire collet 164 disposed within a lumen of the handlepositioning slide 158. The wire collet 164 may be configured to secure adistal end (not explicitly shown) of the guidewire 162 to the handle150. This may allow the guidewire 162 to move in concert with the handle150 (e.g., longitudinally and/or rotationally). The handle 150 mayfurther include a rotating lock nut 160. The lock nut 160 may releasablysecure the wire collet to the handle body 156. In some instances, thelock nut 160 may include an aperture to allow the guidewire 162 to befreely moved and/or exchanged.

In the fully advanced configuration, as shown in FIG. 13 , the guidewire162 has a first length L1 extending distally beyond the flexible taperedtip 26 of the thrombectomy catheter 10. It should be noted that forillustrative purposes only, the smooth catheter tube assembly 19 and theguidewire 162 in FIGS. 13 and 14 are illustrated in a larger scale thanthe braided catheter tube 18, manifold 12 and handle assembly 150. Asdescribed herein, the guidewire 162 may have predetermined bend 170(see, for example, FIG. 15 ) placed at a distance D from the distal tip166. The bend 170 may be positioned between a proximal portion 167 and adistal portion 169 of the guidewire 162 such that a proximal portion 167of the guidewire 162 extends along a longitudinal axis 171 and a distalportion 169 of the guidewires 162 extends an angle θ to the longitudinalaxis 171. The bend 170 may be longitudinally positioned on the guidewire162 such that when the handle 150 is in the fully advanced configuration(FIG. 13 ), the bend 170 is disposed within a lumen (e.g., the lumen 112of the smooth catheter tube 20) of the thrombectomy catheter 10,although this is not required. It is further contemplated that thelocation of the bend 170 relative to the tapered tip 26 of the catheter10 may be further controlled by manipulating where along the length ofthe guidewire 162 the handle assembly 150 is coupled to the guidewire162. For example, the bend 170 may be positioned at a more proximallocation within the catheter 10 by allowing a greater length of theguidewire 162 to extend proximally from the control handle 150.

When in the fully advanced configuration (FIG. 13 ), a first length L1of the guidewire 162 may extend distally beyond the flexible tapered tip26 of the thrombectomy catheter 10. The bend 170 in the guidewire 162may deflect a distal end region 21 of the thrombectomy catheter 10 by afirst angle A1 relative to a longitudinal axis 23 of the catheter tube18 proximal to the bend 170 in the guidewire 162. For example, the bend170 may bias the portion of the catheter tube 18 that is distal to thebend 170 towards a location offset from the longitudinal axis of theportion of the catheter tube 18 that is proximal to the bend 170 (e.g.,towards a vessel wall or thrombus). Deflecting the distal end region 21of the catheter 10 may increase the diametrical sweep coverage R1 of thedistal end region and/or guidewire 162 relative to when no bend 170 ispresent in the guidewire 162. In other words, as the diametrical sweepcoverage R1 increases, the larger a circle the distal end 166 of theguidewire 162 will make when it is rotated. In some cases, the distalend 166 of the guidewire 162 end to the vessel wall (e.g., cover 100% ofthe vessel diameter) and/or be rotated 360° around the circumference ofthe vessel. However, the sweep coverage may be less than a completecircle (e.g., less than 360° of rotation) or may not extend to thevessel wall. In other words, the sweep coverage may be less 100% of thediameter and/or circumference of the vessel lumen. As the deflectionangle increases, the sweep coverage of the distal end region 21 and/orguidewire 162 may also increase. Additionally, deflection of the distalend region 21 may also bring the inflow orifice 24 and jets 140 closerto the thrombus to further facilitate removal of the tissue.

Proximal retraction of the handle body 156, as shown in FIG. 14 , mayproximally retract the guidewire 162 such that a second length L2 of theguidewire 162 extends distally beyond the flexible tapered tip 26 of thethrombectomy catheter 10. The second length L2 may be less than thefirst length L1. It is contemplated that the handle 150 may be used toplace the guidewire distal end or tip 166 in any location between thefully extended and fully retracted positions shown in FIGS. 13 and 14 ,respectively. As the guidewire 162 is proximally retracted, thepredetermined bend 170 in the guidewire 162 is also proximally retractedwithin the lumen (e.g., the lumen 112 of the smooth catheter tube 20) ofthe thrombectomy catheter 10. The greater the distance between thetapered tip or distal end 26 of the thrombectomy catheter 10 and thebend 170 in the guidewire 162, the greater the deflection angle of thedistal end region may be. It is contemplated that the deflection angleA1 in the fully advanced handle configuration (FIG. 13 ) may be smallerthan the deflection angle A2 in the fully retracted handle configuration(FIG. 14 ). For example, FIG. 14 illustrates that the thrombectomycatheter 10 may be deflected by a second angle A2, which may be largerthan the first angle A1. Thus, the sweep coverage R2 of the device whenthe handle is in the fully retracted configuration (FIG. 14 ) may begreater than the sweep coverage of the device when the handle is in thefully advanced configuration (FIG. 13 ). In other words, when rotated,the distal end region 21 of the device 10 may come into contact with agreater cross-section of the vessel when the handle 150 and/or guidewire162 is in a retracted configuration. It is contemplated that theguidewire 162 may be manipulated without the use of control handle 150.For example, the guidewire 162 may be moved proximally and/or distallyand/or rotated through manipulation of the proximal end of the guidewire162 without the use of control handle 150.

FIG. 15 illustrates a schematic side view of a distal portion 168 of theillustrative guidewire 162 having a predetermined bend 170. The bend 170may have a generally smooth curve (e.g., a large radius of curvature) tocreate a gradual bend in the guidewire 162. In some cases, the radius ofcurvature of the bend may be in the range of 1 to 2 millimeters or about1.5 millimeters.

The bend 170 may be positioned a distance D from the distal end 166 ofthe guidewire 162. In some instances, the bend 170 may be positioned inthe range of 0.5 to 20 cm, in the range of 3 to 17 cm, in the range of 7to 15 cm, in the range of 11 to 13 cm, or approximately 12.5 cm from thedistal end 166. However, it is contemplated that the bend 170 may bepositioned less than 0.5 cm or more than 20 cm from the distal end 166as desired. The bend angle θ may be in the range of 1° to 90°, in therange of 10° to 50°, in the range of 15° to 25°, or approximately 20°.However, it is contemplated that the bend angle may be less than 1° orgreater than 90°, as desired. In some cases, the bend angle θ may beselected to achieve a desired sweep coverage.

The guidewire 162 may include an elongate shaft or core wire having aproximal end configured to remain outside the body and a distal end 166.In some instances, the proximal end may have a marker or indictor toprovide the user with information related to the circumferentiallocation of the bend 170 (e.g., to provide a visual indication of whichdirection the bend 170 is angled towards). A coil may be disposed over alength of the core wire adjacent to the distal end. A tip having agenerally curved, atraumatic, shape, such as a solder tip, may be formedon the core wire at or adjacent to the distal end. A portion of the coilmay be coupled to the tip. In some instances, a portion of the coil maybe embedded within the tip. Embedded is understood to be disposedwithin, coupled to, set in, implanted, fixed, etc. The tip may, thus,fix the coil relative to core wire. Alternatively, the coil may besoldered to core wire proximate to the tip. In some instances, the coilmay be replaced with a slotted tube or other flexible member.

The core wire may be comprised of nickel-titanium alloy, stainlesssteel, a composite of nickel-titanium alloy and stainless steel, and/orinclude nickel-cobalt-chromium-molybdenum alloy (e.g., MP35-N).Alternatively, the core wire may be comprised of metals, polymers,combinations or composites thereof, or other suitable materials. In someinstances, a portion or all of the guidewire may be radiopaque to allowthe guidewire to be viewed on a fluoroscopy screen, or other imagingtechnique, during a procedure. In some instances, the distal end and/orcoil may be radiopaque to aid the physician in determining the locationof the distal end of the core wire.

The core wire may be distally tapered. For example, the core wire mayinclude a plurality of distal segments or comprise a single, generallytapered distal end. Each distal segment may comprise a decreased outsidediameter or individual segments may each taper along the length of aparticular segment. A person of ordinary skill in the art couldappreciate that a vast number of alternate configurations of segmentsand distal ends may be included without departing from the scope of theinvention.

The guidewire 162 may have a stiffness that is less than the braidedcatheter shaft 18, but greater than the smooth catheter portion 20. Thismay prevent the proximal portion of the catheter shaft 18 fromdeflecting while allowing the distal portion of the catheter shaft 20 tobe deflected by the predetermined bend 170. In other words, the braidedcatheter shaft 18 may be sufficiently strong to overcome the biasingforce of the bend 170 in the guidewire while the guidewire 162 may besufficiently strong to overcome the biasing force of the smoothercatheter portion 20.

In some instances, a splittable sheath 180 may be used to facilitate theintroduction of the guidewire 162 and/or any other accessory device intoa lumen of the thrombectomy catheter 10, as illustrated in FIGS. 16-20 .The splittable sheath 180 may have a proximal handle portion 182 and adistal portion 184. The handle portion 182 may include a first flange186 and a second flange 188 extending in opposite directions from oneanother. The distal portion 184 of the splittable sheath 180 may besized to fit snugly within a lumen (e.g., the cavity 46 or the cavity 48illustrated in FIG. 3 ) of the cavity body 38 of the manifold 12. Thedistal end portion 184 may be tapered or thinned such that there is noleading “shoulder” during insertion to the manifold 12, although this isnot required. The splittable sheath 180 may also include a region oflongitudinal weakness 190 for splitting the handle 182, which alsoextends toward the distal end 184, allowing for splitting of the sheath180 along its entire length.

A distal end 166 of the guidewire 162, or other accessory device, may beinserted into a lumen of the splittable sheath, as shown in FIG. 16 anddistally advanced until the distal end 151 of the handle 150, if soprovided, is adjacent to the proximal portion 182 of the sheath 180, asshown in FIG. 17 . The splittable sheath 180 may then be split along theregion of longitudinal weakness 190 to allow the guidewire 162 to befurther advanced in the distal direction, as shown in FIGS. 18 and 19 .It is contemplated that once the guidewire 162 is disposed far enoughinto the device 10 that it shouldn’t be accidentally retracted, thesplittable sheath 180 may be disengaged from the manifold 12, althoughthis is not required. As the guidewire 162 is further advanced, thesplittable sheath 180 may be fully removed, as shown in FIG. 20 . Insome instances, the distal end 151 of the handle 150 may be releasablyconnected to the manifold 12, although this is not required.

FIG. 21 illustrates a perspective view of another illustrative accessorydevice 200 that may be used with a thrombectomy catheter, such as thethrombectomy catheter 10 described herein. The accessory device 200 mayinclude a straight or angled (such as the bent guidewire 162 describedherein) guidewire 202 and a cage 204 affixed adjacent to a distal endregion 214 of the guidewire 202. The guidewire 202 may be similar inform and function to the guidewire 162 described herein. However, thepredetermined bend described herein may or may not be present resultingin an angled or straight guidewire, as desired. The proximal end of thedevice 200 may be releasably coupled to a control handle, such as thecontrol handle 150 described herein. Use of the control handle 150 mayallow the device 200 to be retracted, deployed, and rotated in acontrolled manner, although its use is not required.

The cage 204 may comprise a plurality of struts, strands, or groups ofwires 208 a, 208 b, 208 c, 208 d (collectively, 208). While the cage 204is illustrated as having four strands 208, it is contemplated that thecage 204 may include any number of strands 208, such as but not limitedone, two, three, four, or more, as desired. In some cases, the cage 204may include twenty or more strands 208. In some instances, each strand208 may be comprised of two or more individual wires 216 a, 216 b,although this is not required. In some embodiments, each strand 208 maybe formed from a single wire or strut. In other cases, the strands 208may include up to five or more individual wires per strand 208. Thestrands 208 and/or wires 216 a, 216 b may be made from stainless steelor a shape memory material such as, but not limited to nitinol. Thestiffness of the strands 208 may be varied as desired. In someinstances, the strands 208 may be provided with serrations and/or sharpedges to aid in clot maceration. In some embodiments, the outer mostpart of the strands 208 may remain smooth since this will be the partthat may contact the vessel wall and help center the device.

The strands 208 may be affixed to one another at their proximal ends 210and distal ends 212. The proximal end 210 may be affixed to the distalend region 214 of the guidewire 202. The distal end 212 may be affixedto a solid or tubular distal extension 206. It is contemplated that thedistal extension 206 may facilitate distal advancement of the device 200through a lesion. The strands 208 may have a generally spiral or helicalpattern extending from the proximal end 210 to the distal end 212,although this is not required. For example, the proximal end 210 and thedistal end 211 of a given strand 208 may be circumferentially offsetfrom one another. It is contemplated that different spiral patternscould be used to aid in clot maceration. The strands 208 may be evenlyspaced or eccentrically spaced as desired. While the strands 208 havebeen described as wires, it is contemplated that the cage 204 may beformed from a cut tube. It is further contemplated that the cage 204 maybe self-expanding or include an actuation mechanism to manually deploythe cage 204. The cage 204 may be collapsible into a deliveryconfiguration which may have a smaller cross-sectional area and a longerlength than the expanded cage 204 illustrated in FIG. 21 .

FIG. 22 is a side view of the distal region of the cross streammechanical thrombectomy catheter 10 showing in particular the distal endof the smooth catheter tube assembly 19 positioned in a blood vessel 220(shown in cross section) at a site of a thrombotic deposit or lesion 222with accessory device 200 extending distally therefrom. It iscontemplated that the device 200 may be loaded into a lumen of athrombectomy catheter 10 in a similar manner to that described hereinwith respect to FIGS. 16-20 . While FIG. 22 depicts the smooth cathetertube assembly 19 as being in a blood vessel in particular, it is to beunderstood that it is not limited to use in a blood vessel but hasutility with respect to any body cavity in general. High velocity fluidjets (such as jets 136 a-136 n shown in FIG. 10 ) of saline or othersuitable solution are emanated or emitted in a proximal direction fromthe fluid jet emanator 116 into the smooth catheter tube 20 and passthrough the outflow orifice 22 creating cross stream jets 140 a-140 ndirected toward the wall of the blood vessel 220 having thromboticdeposits or lesions 222 and thence are influenced by the low pressure atthe inflow orifice 24 to cause the cross stream jets 140 a-140 n to bedirected distally substantially parallel to the central axis of theblood vessel 220 to impinge and break up thrombotic deposits or lesions222 and to, by entrainment, urge and carry along the dislodged andablated thrombotic particulates 224 of the thrombotic deposits orlesions 222 through the inflow orifice 24, a relatively low pressureregion, and into the lumen 112, which functions as a recyclingmaceration lumen or chamber and also as an exhaust lumen. Theentrainment through the inflow orifice 24 is based on entrainment by thehigh velocity fluid jets 136 a-136 n. The outflow is driven by internalpressure which is created by the high velocity fluid jets 136 a-136 nand the fluid entrained through the inflow orifice 24.

The accessory guidewire based device 200 with the spiral cage 204 on thedistal end may be advanced through the guidewire or aspiration lumen ofthe thrombectomy catheter 10. The device 200 can be operated in apecking motion, dragging motion, or manually rotated to help aid in thedisruption of the lesion 222. This may increase removal and/or shorten aprocedure when combined with the evacuative and shearing properties ofthe thrombectomy catheter 10. Furthermore, the cage 204 may beretracted, rotated, and deployed with a special handle, as describedherein with respect to FIGS. 13 and 14 . It is contemplated that thecage 204 may also be driven by a motor (rotationally and/orlongitudinally). As described herein, the device 200 may also have abent guidewire 202 to deflect the distal end region of the thrombectomycatheter 10 relative to a longitudinal axis of the catheter tube 18proximal to the bend in the guidewire 202. Deflecting the distal endregion of the catheter 10 may increase the sweep coverage of the distalend region and/or device 200. For example, as the deflection angleincreases, the sweep coverage of the distal end region and/or guidewire202 may also increase. Additionally, deflection of the distal end regionof the catheter 10 may also bring the inflow window and jets closer tothe thrombus to further facilitate removal of the tissue. It iscontemplated that the accessory device 200 should not cause anyadditional hemolysis since the shear rate for blood cells is notexceeded in the arrangement.

FIG. 23 illustrates a side view of another illustrative accessory device250 that may be used with a thrombectomy catheter, such as thethrombectomy catheter 10 described herein. The accessory device 250 mayinclude a straight or angled (such as the bent guidewire 162 describedherein) guidewire 252 and a bi-strut cage 254 attached adjacent to adistal end region 258 of the guidewire 252. The guidewire 252 may besimilar in form and function to the guidewire 162 described herein.However, the predetermined bend 170 described herein may or may not bepresent resulting in an angled or straight guidewire, as desired. Theproximal end of the device 250 may be releasably coupled to a controlhandle, such as the control handle 150 described herein. Use of thecontrol handle 150 may allow the device 250 to be retracted, deployed,and rotated in a controlled manner, although its use is not required.

The cage 254 may comprise two struts 256 a, 256 b (collectively, 256).While the cage 254 is illustrated as having two struts 256, it iscontemplated that the cage 254 may include any number of struts 256,such as but not limited one, two, three, four, or more, as desired. Insome instances, each strut 208 may be comprised of two or moreindividual wires (not explicitly shown), although this is not required.In some embodiments, each strut 256 may be formed from a single wire orstrut. The struts 256 may be made from stainless steel or a shape memorymaterial such as, but not limited to nitinol. The stiffness of thestruts 256 may be varied as desired. In some instances, the struts 256may be provided with serrations and/or sharp edges to aid in clotmaceration. In some instances, the struts 256 may be formed from cuttingblades. In some embodiments, the blades may have one edge that issharper than the other edge. This may require the device to be rotatedin a specific direction to achieve cutting. In some embodiments, theouter most part of the struts 256 may remain smooth since this will bethe part that may contact the vessel wall and help center the device.

The struts 256 may be affixed to one another and/or the guidewire 252 attheir proximal ends 260 and distal ends 262. It is contemplated that theguidewire 252 may extend distally beyond the distal end 262 of the cage254 to facilitate distal advancement of the device 250 through a lesion.The struts 256 may each have a generally arced or curved configuration,although other structures are contemplated. The struts 256 may be evenlyspaced or eccentrically spaced as desired. For example, the struts 256may be positioned approximately 180° from one another. It is furthercontemplated that the cage 254 may be self-expanding or include anactuation mechanism to manually deploy the cage 254. The cage 254 may becollapsible into a delivery configuration which may have a smallercross-sectional area and a longer length than the expanded cage 254illustrated in FIG. 23 . While not explicitly shown, a spring may beprovided on the guidewire 252 between the proximal and distal ends 260,262 of the cage 254 to bias the cage 254 into the deliveryconfiguration.

The accessory guidewire based device 250 with the bi-strut cage 254 onthe distal end may be advanced through the guidewire or aspiration lumenof the thrombectomy catheter 10. The device 250 can be operated in apecking motion, dragging motion, or manually rotated to help aid in thedisruption of the lesion. This may increase removal or shorten aprocedure when combined with the evacuative and shearing properties ofthe thrombectomy catheter 10. Furthermore, the cage 254 may beretracted, rotated, and deployed with a special handle, as describedherein with respect to FIGS. 13 and 14 . It is contemplated that thecage 254 may also be driven by a motor (rotationally and/orlongitudinally). For example, rapid rotation, in the range of 20 to10,000 rpm may be provided by an externally located motor to maceratethe clot. As described herein, the device 250 may also have a bentguidewire 252 to deflect the distal end region of the thrombectomycatheter 10 relative to a longitudinal axis of the catheter tubeproximal to the bend in the guidewire 252. Deflecting the distal endregion of the catheter 10 may increase the sweep coverage of the distalend region and/or device 250. For example, as the deflection angleincreases, the sweep coverage of the distal end region of the catheter10 and/or guidewire 252 may also increase. Additionally, deflection ofthe distal end region of the catheter 10 may also bring the infloworifice or window 24 and jets 140 a-140 n closer to the thrombus tofurther facilitate removal of the tissue. It is contemplated that theaccessory device 250 should not cause any additional hemolysis since theshear rate for blood cells is not exceeded in the arrangement.

FIG. 24 illustrates a side view of another illustrative accessory device300 that may be used with a thrombectomy catheter, such as thethrombectomy catheter 10 described herein. The accessory device 300 mayinclude an expandable basket 302 positioned over the catheter tube 20adjacent to the outflow orifice 22 and the inflow orifice 24. The basket302 may comprise a plurality of longitudinally extending struts 304 a,304 b, 304 c (collectively, 304). It is contemplated that the basket 302may include any number of struts 304, such as but not limited one, two,three, four, or more, as desired. In some instances, each strut 304 maybe comprised of two or more individual wires (not explicitly shown),although this is not required. In some embodiments, each strut 304 maybe formed from a single wire or strut. The struts 304 may be made fromstainless steel or a shape memory material such as, but not limited tonitinol. The stiffness of the struts 304 may be varied as desired. Insome instances, the struts 304 may be provided with serrations and/orsharp edges to aid in clot maceration. In some embodiments, the outermost part of the struts 304 may remain smooth since this will be thepart that may contact the vessel wall and help center the device.

The struts 304 may be affixed to and/or over the catheter tube 20 at aproximal end connection 306 of the basket 302 and a distal endconnection 308 of the basket 302. It is contemplated that one of theproximal end connection 306 or the distal end connection 308 may befixedly secured to the catheter tube 20 while the other connection maybe slidably disposed over the catheter tube 20. This may allow thebasket 302 to maintain a desired longitudinal positon along the cathetertube 20 while allowing the basket 302 to assume a delivery configurationin which the basket has a smaller cross-sectional area and a longerlength than the expanded basket 302 illustrated in FIG. 24 .

The struts 304 may be evenly spaced or eccentrically spaced as desired.For example, the struts 304 may uniformly distributed about thecircumference of the catheter tube 20, eccentrically distributed, and/orweighted to one side. These are just examples. It is furthercontemplated that the basket 302 may be self-expanding or include anactuation mechanism to manually deploy the basket 302.

In some instances, the device 300 may be used in combination with a bentguidewire, such as the guidewire 162 described herein. This may deflectthe distal end region of the thrombectomy catheter 10 relative to alongitudinal axis of the catheter tube proximal to the bend 170 in theguidewire 162. Deflecting the distal end region of the catheter 10 mayincrease the sweep coverage of the distal end region of the catheter10and/or device 300. For example, as the deflection angle increases, thesweep coverage of the distal end region and/or device 300 may alsoincrease. Additionally, deflection of the distal end region of thecatheter 10 may also bring the inflow window 24 and jets 140 a-140 ncloser to the thrombus to further facilitate removal of the tissue. Itis contemplated that the accessory device 300 should not cause anyadditional hemolysis since the shear rate for blood cells is notexceeded in the arrangement.

FIG. 25 illustrates a side view of another illustrative accessory device350 that may be used with a thrombectomy catheter, such as thethrombectomy catheter 10 described herein. The accessory device 350 mayinclude a straight or angled (such as the bent guidewire 162 describedherein) proximally extending portion 352 and an expandable basket 354.It is contemplated that the proximally extending portion 352 may have apredetermined bend configured to angle a distal portion of the device350 relative to the longitudinal axis of the device 350 proximal to thebend, although this is not required. The proximal end of the device 350may be releasably coupled to a control handle, such as the controlhandle 150 described herein. Use of the control handle 150 may allow thedevice 350 to be retracted, deployed, and rotated in a controlledmanner, although its use is not required.

In some instances, the proximally extending portion 352 may be formedfrom two longitudinally extending strands 356, 358. The strands 356, 358may each be formed from a plurality of individual filaments 356 a, 356b, 356 c, 356 d, 358 a, 358 b, 358 c, 358 d. It is contemplated thattwo, three, four, or more individual filaments may be wound, woven, orbraided together to form the strands 356, 358. The proximally extendingportion 352 may be disposed within a tube, such as polymeric tube, tomaintain the strands 356 in close proximity during advancement of thedevice within the catheter 10. This may facilitate advancement of thedevice 300, reduce the potential of the device 350 to snag, and/or helpwith pushablility, among other features. The tube may not extend theentire length of the device. For example, the tube may terminate alocation 362 proximal to the distal end of the device 350. This mayallow the strands 356, 358 to separate as they are advanced distallybeyond the distal end 26 of the catheter 10

The first strand 356 may not be woven or wound along its entire length.For example at location 364, the filaments 356 a, 356 b, 356 c, 356 dmay be separated and spread apart to form a basket type structure. Thefilaments 356 a, 356 b, 356 c, 356 d may be made from stainless steel ora shape memory material such as, but not limited to nitinol. Thematerial may be selected to allow the filaments to assume an expandedconfiguration when the basket is deployed. Similarly, the second strand358 may not be woven or wound along its entire length. For example atlocation 366, the filaments 358 a, 358 b, 358 c, 358 d may be separatedand spread apart to form a basket type structure. The filaments 358 a,358 b, 358 c, 358 d may be made from stainless steel or a shape memorymaterial such as, but not limited to nitinol. The material may beselected to allow the filaments to assume an expanded configuration whenthe basket is deployed. The expandable basket 354 may have a partiallyclosed configuration. For example, the proximal end 368 of the basket354 may be more “open” than the distal end 370 where filaments 356 a,356 b, 356 c, 356 d, 358 a, 358 b, 358 c, 358 d come together. Two largelong openings 372 a, 372 b may extend along the sides of the basket 354(e.g., each long opening extending between the first filaments 356 a,356 b, 356 c, 356 d, and the second filaments 358 a, 358 b, 358 c, 358d). It is contemplated that the basket 354 may be self-expanding orinclude an actuation mechanism to manually deploy the basket 354. Thebasket 354 may be collapsible into a delivery configuration which mayhave a smaller cross-sectional area and a longer length than theexpanded basket 354 illustrated in FIG. 25 .

Distal to the distal end 370 of the basket 354, the filaments 356 a, 356b, 356 c, 356 d, 358 a, 358 b, 358 c, 358 d may be surrounded by a tube,such as a polymer tube 360 to maintain the filaments in a confinedarrangement. The polymer tube 360 may extend distally of the basket 354to facilitate advancement of the device 300 through a lesion.

The accessory guidewire based device 350 with the expandable basket 354may be advanced through the guidewire or aspiration lumen of thethrombectomy catheter 10. The device 350 can be operated in a peckingmotion, dragging motion, or manually rotated to help aid in thedisruption of the lesion. This may increase removal or shorten aprocedure when combined with the evacuative and shearing properties ofthe thrombectomy catheter 10. Furthermore, the basket 354 may beretracted, rotated, and deployed with a special handle, as describedherein with respect to FIGS. 13 and 14 . It is contemplated that thedevice 350 may also be driven by a motor (rotationally and/orlongitudinally). Deflecting the distal end region of the catheter 10 mayincrease the sweep coverage of the distal end region of the catheter 10and/or the accessory device 350. For example, as the deflection angleincreases, the sweep coverage of the distal end region of the catheter10 and/or basket 354 may also increase. Additionally, deflection of thedistal end region of the catheter 10 may also bring the inflow window 24and jets 140 a-140 n closer to the thrombus to further facilitateremoval of the tissue. It is contemplated that the accessory device 350should not cause any additional hemolysis since the shear rate for bloodcells is not exceeded in the arrangement.

FIG. 26 illustrates a side view of another illustrative accessory device400 that may be used with a thrombectomy catheter, such as thethrombectomy catheter 10 described herein. The accessory device 400 mayinclude a straight or angled (such as the bent guidewire 162 describedherein) tubular member or guidewire 402 and an expandable cage 404extending from a distal end region 406 of the guidewire 402. Theguidewire 402 may be similar in form and function to the guidewire 162described herein. However, the predetermined bend 170 described hereinmay or may not be present resulting in an angled or straight guidewire,as desired. Alternatively, or additionally, the guidewire 402 may be atubular member having a lumen extending therethrough. The expandablecage 404 may be slidably disposed through the lumen of the tubularmember. The proximal end of the device 400 may be releasably coupled toa control handle, such as the control handle 150 described herein. Useof the control handle 150 may allow the device 400 to be retracted,deployed, and rotated in a controlled manner, although its use is notrequired.

The cage 404 may comprise a plurality of collapsible struts 408 a, 408b, 408 c, 408 d (collectively, 408). While the cage 404 is illustratedas having four struts, it is contemplated that the cage 404 may includeany number of struts 408, such as but not limited one, two, three, four,or more, as desired. In some instances, each strut 408 may be comprisedof two or more individual wires (not explicitly shown), although this isnot required. In some embodiments, each strut 408 may be formed from asingle wire or strut. The struts 408 may be made from stainless steel ora shape memory material such as, but not limited to nitinol. Thestiffness of the struts 408 may be varied as desired. In some instances,the struts 408 may be provided with serrations and/or sharp edges to aidin clot maceration. In some embodiments, the outer most part of thestruts 408 may remain smooth since this will be the part that maycontact the vessel wall and help center the device.

The struts 408 may be evenly spaced or eccentrically spaced as desired.For example, in some cases, the struts 408 may be positionedapproximately 90° from one another. It is further contemplated that thecage 404 may be self-expanding or include an actuation mechanism tomanually deploy the cage 404. The cage 404 may be collapsible into adelivery configuration which may have a smaller cross-sectional area anda longer length that the expanded cage 404 illustrated in FIG. 26 .

The struts 408 may be affixed to one another and/or the guidewire 402and/or a central shaft 416 at their collective proximal end 420. Thedistal ends 422 a, 422 b, 422 c, 422 d (collectively 422) of the struts408 may be biased outward in an expanded configuration (shown in FIG. 26). The distal ends 422 may have a protective safety band 418 connectedthereto and extending around a perimeter of the distal end of the cage404. The safety band 418 may be made of a flexible material orstructured to have a collapsed configuration to allow it to be collapsedinto a reduced profile delivery configuration. A central shaft 416 maybe extend longitudinally through a center of the cage 404. A rotatablepropeller 410 may be rotationally affixed to the distal end 424 of thecentral shaft 416. The propeller 410 may include a plurality of blades412 a, 412 b, 412 c, 412 d (collectively, 412). While the propeller 410is illustrated as having four blades 412, it is contemplated that thepropeller 410 may include any number of blades 412, such as but notlimited one, two, three, four, or more, as desired. The blades 412 maybe configured to draw any clot or debris towards the thrombectomycatheter 10. For example, the pitch and rotational direction of theblades 412 may be configured to draw any clot or debris towards thethrombectomy catheter 10. The propeller 410 may be electricallyconnected to a motor configured to remain outside the body to driverotation of the propeller 410.

The accessory guidewire based device 400 with the expandable cage 404 onthe distal end may be advanced through the guidewire or aspiration lumenof the thrombectomy catheter 10. The device 400 can be operated in apecking motion, dragging motion, or manually and/or electrically rotatedto help aid in the disruption of the lesion. This may increase removalor shorten a procedure when combined with the evacuative and shearingproperties of the thrombectomy catheter 10. Furthermore, the cage 404may be retracted, rotated, and deployed with a special handle, asdescribed herein with respect to FIGS. 13 and 14 . As described herein,the device 400 may also have a bent guidewire 402 to deflect the distalend region of the thrombectomy catheter 10 relative to a longitudinalaxis of the catheter tube proximal to the bend in the guidewire 402.Deflecting the distal end region of the catheter 10 may increase thesweep coverage of the distal end region and/or device 400. For example,as the deflection angle increases, the sweep coverage of the distal endregion of the catheter 10 and/or guidewire 402 may also increase.Additionally, deflection of the distal end region of the catheter 10 mayalso bring the inflow window 24 and jets 140 a-140 n closer to thethrombus to further facilitate removal of the tissue. It is contemplatedthat the accessory device 400 should not cause any additional hemolysissince the shear rate for blood cells is not exceeded in the arrangement.

FIGS. 27-31 each illustrate a side view of another illustrativeaccessory device 450 that may be used with a thrombectomy catheter, suchas the thrombectomy catheter 10 described herein. The accessory device450 may include a straight or angled (such as the bent guidewire 162described herein) tubular member or guidewire 452. It is contemplatedthat the guidewire 452 may be a solid core wire, a traditional guidewirestructure, or a tubular member, as desired. In some instances, theguidewire 452 may be similar in form and function to the guidewire 162described herein. However, the predetermined bend 170 described hereinmay or may not be present resulting in an angled or straight guidewire,as desired. The proximal end of the device 450 may be releasably coupledto a control handle, such as the control handle 150 described herein.Use of the control handle 150 may allow the device 450 to be retracted,deployed, and rotated in a controlled manner, although its use is notrequired.

In some instances, a distal region of the guidewire 452 may have adisruption feature 454 configured to facilitate clot maceration. It iscontemplated that the disruption feature 454 may be configured toincrease the sweep coverage of the guidewire 452. The disruption feature454 may take a variety of forms including, but not limited to a bend orcurve 456 (FIG. 27 ), a loop 458 (FIG. 28 ), a plurality of loops 460(FIG. 29 ), an angled tip 462 (FIG. 30 ), a tapered spiral 464 (FIG. 31), or combinations thereof. These are just examples. Other structuresare also envisioned, including but not limited a uniform diameter coil,a coil having varying pitch, a curved tip, etc. The guidewire 452 may bemade from stainless steel or a shape memory material such as, but notlimited to nitinol. The stiffness of the guidewire 452 may be varied asdesired.

The accessory guidewire based device 450 may be advanced through theguidewire or aspiration lumen of the thrombectomy catheter 10. Thedevice 450 can be operated in a pecking motion, dragging motion, ormanually and/or electrically rotated to help aid in the disruption ofthe lesion. This may increase removal or shorten a procedure whencombined with the evacuative and shearing properties of the thrombectomycatheter 10. Furthermore, the device 450 may be retracted, rotated, anddeployed with a special handle, as described herein with respect toFIGS. 13 and 14 . As described herein, the device 450 may also have abent guidewire 452 to deflect the distal end region of the thrombectomycatheter 10 relative to a longitudinal axis of the catheter tubeproximal to the bend in the guidewire 452. It is contemplated that if soprovided, the bend may be positioned proximal to the disruption feature.Deflecting the distal end region of the catheter 10 may further increasethe sweep coverage of the distal end region of the catheter 10 and/ordevice 450. For example, as the deflection angle increases, the sweepcoverage of the distal end region and/or guidewire 452 may alsoincrease. Additionally, deflection of the distal end region of thecatheter 10 may also bring the inflow window 24 and jets 140 a-140 ncloser to the thrombus to further facilitate removal of the tissue. Itis contemplated that the accessory device 450 should not cause anyadditional hemolysis since the shear rate for blood cells is notexceeded in the arrangement.

FIGS. 32-34 illustrate another illustrative accessory device 500 thatmay be used with a thrombectomy catheter, such as the thrombectomycatheter 10 described herein. The accessory device 500 may include acore wire 502 and an expandable cage 504 positioned adjacent to a distalend of the core wire 502. The proximal end of the device 500 may bereleasably coupled to a control handle, such as the control handle 150described herein. Use of the control handle 150 may allow the device 500to be retracted, deployed, and rotated in a controlled manner, althoughits use is not required.

The cage 504 may be formed from a laser cut nitinol tube, although othermaterials may also be used. The tube may be cut to form a lattice orwoven type structure. Alternatively, the cage 504 may be formed from aplurality of wound or woven filaments. The cage 504 may be coupled atits distal end to the distal end of the core wire 502 at a distal collar508. A proximal collar 506 may be positioned on or adjacent to the tip26 of the thrombectomy catheter 10. The device 500 may be advanced withthe thrombectomy catheter 10 or may be advanced through a lumen of thethrombectomy catheter 10 after the catheter 10 has been positionedadjacent to the lesion, as desired. In some instances, the device 500may be formed as a component of the catheter 10. It is contemplated thatthe cage 504 may be configured to be advanced distally beyond the distalend of the catheter 10 or may be formed as a distal extension to thecatheter 10.

The cage 504 may have a collapsed, low-profile, delivery configuration,as shown in FIG. 32 . Once the device 500 is positioned adjacent to thelesion, the core wire 502 may be proximally retracted to expand the cage504, as shown in FIG. 33 . Additional proximal actuation of the corewire 502 may fully expand the cage 504, as shown in FIG. 34 . It isfurther contemplated that proximal actuation of the core wire 502 mayalso result in proximal movement of the cage 504. This may position thecage 504 over the inflow window 24. It is contemplated that the cage 504may break up the lesion(s) near the window 24 to allow for easier debrisremoval.

The device 500 can be operated in a pecking motion, dragging motion, ormanually and/or electrically rotated to help aid in the disruption ofthe lesion. This may increase removal or shorten a procedure whencombined with the evacuative and shearing properties of the thrombectomycatheter 10. Furthermore, the cage 504 may be retracted, rotated, anddeployed with a special handle, as described herein with respect toFIGS. 13 and 14 . It is contemplated that the accessory device 500should not cause any additional hemolysis since the shear rate for bloodcells is not exceeded in the arrangement.

FIG. 35A illustrates a side view of another illustrative accessorydevice 550 that may be used with a thrombectomy catheter, such as thethrombectomy catheter 10 described herein. FIG. 35B illustrates a distalend view of the accessory device 550. The device 550 is shown in FIG.35A disposed within a vessel 580 (shown in cross-section) having alesion 582. The accessory device 550 may include a guidewire 552 and arotatable cage 554 positioned adjacent to a distal end of the core wire502. The proximal end of the device 550 may be releasably coupled tocontrol handle, such as control handle 150 described herein. Use of thecontrol handle 150 may allow the device 550 to be retracted, deployed,and rotated in a controlled manner.

The guidewire 552 may include a first bend 556 configured to bias aportion of the device 550 towards a wall of the vessel 580 and/or thelesion 582. The guidewire 552 may include a second bend 558 configuredto direct the cage 554 towards the center of vessel 580. It is furthercontemplated that the structure of the guidewire 552 may prevent thecatheter 10 from bouncing off of the lesion 582. The guidewire 552 maybe attached to the rotatable cage 554 at a rotating joint 560 such thatthe cage 554 is articulated as the guidewire 552 is manually torqued.The roatating joint 560 may be, for example, a ball and socket or hinge.A distal end view of the cage 554 is illustrated in FIG. 35B. The cage554 may include a plurality of petal-like strands 562. In the expandedconfiguration, the cage 554 may be postioned in a plane extendinggenerally orthogonal to a longitudinal axis of the vessel. The cage 554may be formed from one or more of wound or woven filaments. The cage 554may act as a filter to help prevent debris from the lesion 582 frombeing swept downstream.

It is further contemplated that the cage 554 may be self-expanding orinclude an actuation mechanism to manually deploy the cage 554. The cage554 may be collapsible into a delivery configuration which may have asmaller cross-sectional area and a longer length than the expanded cage554 illustrated in FIG. 35A.

The materials that can be used for the various components of thecatheter, guidewires, accessory device, and/or other devices disclosedherein may include those commonly associated with medical devices. Forsimplicity purposes, the following discussion makes reference toaccessory devices and their related components. However, this is notintended to limit the devices and methods described herein, as thediscussion may be applied to other similar devices, tubular membersand/or components of tubular members or devices disclosed herein.

The various components of the devices/systems disclosed herein mayinclude a metal, metal alloy, polymer (some examples of which aredisclosed herein), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable metals and metal alloys include stainless steel, such as 304V,304L, and 316LV stainless steel; mild steel; nickel-titanium alloy suchas linear-elastic and/or super-elastic nitinol; other nickel alloys suchas nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;combinations thereof; and the like; or any other suitable material.

Some examples of suitable polymers may include polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example, DELRIN® availablefrom DuPont), polyether block ester, polyurethane (for example,Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC),polyether-ester (for example, ARNITEL® available from DSM EngineeringPlastics), ether or ester based copolymers (for example,butylene/poly(alkylene ether) phthalate and/or other polyesterelastomers such as HYTREL® available from DuPont), polyamide (forexample, DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide/ethers, polyetherblock amide (PEBA, for example available under the trade name PEBAX®),ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE),Marlex high-density polyethylene, Marlex low-density polyethylene,linear low density polyethylene (for example REXELL®), polyester,polybutylene terephthalate (PBT), polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS A),polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In at least some embodiments, portions or all of the accessory devicesand their related components may be doped with, made of, or otherwiseinclude a radiopaque material. Radiopaque materials are understood to bematerials capable of producing a relatively bright image on afluoroscopy screen or another imaging technique during a medicalprocedure. This relatively bright image aids the user of the accessorydevices and their related components in determining its location. Someexamples of radiopaque materials can include, but are not limited to,gold, platinum, palladium, tantalum, tungsten alloy, polymer materialloaded with a radiopaque filler, and the like. Additionally, otherradiopaque marker bands and/or coils may also be incorporated into thedesign of the accessory devices and their related components to achievethe same result.

EXAMPLES

In a first example, a thrombectomy catheter may comprise a catheter bodyextending from a catheter proximal portion to a catheter distal portionand including a catheter lumen extending between the proximal portionand the distal portion, a high pressure tube extending through thecatheter lumen from the catheter proximal portion toward the catheterdistal portion, the high pressure tube configured for communication witha fluid source near the catheter proximal portion, a fluid jet emanatorin communication with the high pressure tube, the fluid jet emanatorhaving at least one jet orifice for directing at least one fluid jetfrom said fluid jet emanator through the catheter lumen, an outfloworifice located along a catheter perimeter of the catheter distalportion, an entrainment inflow orifice positioned along the catheterdistal portion, and an accessory device disposed within the catheterlumen.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may comprise a guidewire having proximalend portion and a distal end portion.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may comprise an elongate core wire having a coildisposed over a length of the core wire adjacent to a distal end of thecore wire.

Alternatively or additionally to any of the examples above, in anotherexample, the proximal portion of the guidewire may extend along alongitudinal axis and the distal portion of the guidewire may beconfigured to extend at an angle to the longitudinal axis.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 1 to 90°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 10 to 60°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 10 to 30°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 15 to 25°.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be approximately 20°.

Alternatively or additionally to any of the examples above, in anotherexample, the guidewire may comprise a bent portion disposed between theproximal end portion and the distal end portion of the guidewire.

Alternatively or additionally to any of the examples above, in anotherexample, the bent portion of the guidewire may be configured to deflecta portion of the catheter body positioned distal to the bend portion.

Alternatively or additionally to any of the examples above, in anotherexample, when the bend portion is positioned at a first longitudinallocation within the catheter lumen, the thrombectomy catheter may have afirst diametrical sweep coverage and when the bend portion is positionedat a second longitudinal location within the catheter lumen, the secondlocation proximal to the first location, the thrombectomy catheter mayhave a second diametrical sweep coverage greater than the firstdiametrical sweep coverage.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be slidably disposed within thecatheter lumen.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be rotationally disposed within thecatheter lumen.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise an expandablecage positioned adjacent to a distal end of the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be a cut tube.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may comprise a plurality of strandsextending from a proximal end of the cage to a distal end of the cage.

Alternatively or additionally to any of the examples above, in anotherexample, each strand of the plurality of strands may be formed from twoor more wires.

Alternatively or additionally to any of the examples above, in anotherexample, a proximal end and a distal end of each strand of the pluralityof strands may be coupled to the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration to an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be self-expanding.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise an actuationmechanism, the actuation mechanism may be configured to move theexpandable cage between the collapsed configuration and the expandedconfiguration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the strands may be configured tocurve away from a longitudinal axis of the accessory device along alength of the strands such that a cross-sectional diameter of the cagein the expanded configuration is larger than a cross-sectional diameterof the cage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strand of the plurality ofstrands may have a generally helically shape such that a distal end ofeach strand is circumferentially offset form a proximal end of thestrand.

Alternatively or additionally to any of the examples above, in anotherexample, the thrombectomy catheter may further comprise a control handlereleasably secured adjacent to a proximal end of the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may comprise a body portion, a slideportion, and a collet portion.

Alternatively or additionally to any of the examples above, in anotherexample, the collet portion may be configured to be releasably securedto the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the body portion and the collet portion may be configured toactuate relative to the slide portion.

Alternatively or additionally to any of the examples above, in anotherexample, the body portion and the collet portion may be configured toactuate along a longitudinal axis of the control handle.

Alternatively or additionally to any of the examples above, in anotherexample, actuating the body portion and the collet portion may move thehandle between an extended configuration and a retracted configuration.

Alternatively or additionally to any of the examples above, in anotherexample, actuating the body portion and the collet portion may result inproximal and/or distal movement of the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the control handle may be configured to rotate independent ofthe catheter body.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be configured to rotate with rotationof the control handle.

Alternatively or additionally to any of the examples above, in anotherexample, the outflow orifice may be configured to generate a jet streamout of the catheter body with the at least one fluid jet, the jet streamincluding first and second stream portions.

Alternatively or additionally to any of the examples above, in anotherexample, the entrainment inflow orifice may be configured to receive thejet stream first portion and direct the jet stream first portion andentrained particulate toward the outflow orifice.

In another illustrative example, an accessory device for use with amedical device may comprise an elongated core wire having proximalportion, a distal portion, and a curved portion disposed between theproximal portion and the distal portion, wherein the proximal portion ofthe core wire extends along a longitudinal axis and the distal portionof the core wire extends from the curved portion at an angle to theproximal portion.

Alternatively or additionally to any of the examples above, in anotherexample, the core wire may be configured to be slidably and/orrotationally disposed within a lumen of the medical device.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may be configured to deflect distal endregion of the medical device from a longitudinal axis of the medicaldevice.

Alternatively or additionally to any of the examples above, in anotherexample, an amount of deflection of the distal end region may vary witha longitudinal location of the curved portion of the core wire.

Alternatively or additionally to any of the examples above, in anotherexample, the angle may be in the range of 1 to 45°.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may further comprise an expandable cagepositioned adjacent the distal end portion of the core wire.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may comprise a plurality of strutsextending from a proximal end of the cage to a distal end of the cage.

Alternatively or additionally to any of the examples above, in anotherexample, each strut of the plurality of struts may be formed from two ormore wires.

Alternatively or additionally to any of the examples above, in anotherexample, a proximal end and a distal end of each strut of the pluralityof struts may be coupled to the accessory device.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration to an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the struts may be configured tocurve away from a longitudinal axis of the accessory device along alength of the struts such that a cross-sectional diameter of the cage inthe expanded configuration maybe larger than a cross-sectional diameterof the cage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strut of the plurality ofstruts may have a generally helically shape such that a distal end ofeach strut is circumferentially offset form a proximal end of saidstrut.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may further comprise a control handlereleasably coupled adjacent to a proximal end of the core wire.

In another example, an accessory device for use with a medical devicemay comprise an elongated member having proximal portion and a distalportion an expandable cage comprising a plurality of longitudinallyextending struts, the expandable cage disposed adjacent to the distalportion of the elongated member such that a length of the distal portionextends distally beyond a distal end of the expandable cage.

Alternatively or additionally to any of the examples above, in anotherexample, the elongated member may be configured to be slidably and/orrotationally disposed within a lumen of the medical device.

Alternatively or additionally to any of the examples above, in anotherexample, the elongated member may comprise a tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, the struts of the expandable cage may be formed by removingmaterial from the tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration to an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the struts may be configured tocurve away from a longitudinal axis of the accessory device along alength of the struts such that a cross-sectional diameter of the cage inthe expanded configuration may be larger than a cross-sectional diameterof the cage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strut of the plurality ofstruts may have a generally helically shape such that a distal end ofeach strut is circumferentially offset form a proximal end of saidstrut.

Alternatively or additionally to any of the examples above, in anotherexample, the elongated member may comprise a solid core wire.

Alternatively or additionally to any of the examples above, in anotherexample, each strut of the plurality of struts may be formed from two ormore wires.

Alternatively or additionally to any of the examples above, in anotherexample, a proximal end and a distal end of each strut of the pluralityof struts may be coupled to the core wire.

Alternatively or additionally to any of the examples above, in anotherexample, the expandable cage may be configured to move between acollapsed configuration to an expanded configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, the struts may be configured tocurve away from a longitudinal axis of the accessory device along alength of the struts such that a cross-sectional diameter of the cage inthe expanded configuration may be larger than a cross-sectional diameterof the cage in the collapsed configuration.

Alternatively or additionally to any of the examples above, in anotherexample, in the expanded configuration, each strut of the plurality ofstruts may have a generally helically shape such that a distal end ofeach strut is circumferentially offset form a proximal end of saidstrut.

Alternatively or additionally to any of the examples above, in anotherexample, the accessory device may further comprise a control handlereleasably coupled adjacent to a proximal end of the elongated member.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention’s scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A method of treating thrombus in a bold vessel,the method comprising: advancing a thrombectomy catheter through a bloodvessel to a target location, the thrombectomy catheter comprising: acatheter body extending from a proximal portion to a distal portion andincluding a catheter lumen extending between the proximal portion andthe distal portion; and a thrombus disrupting member disposed within thecatheter lumen, the thrombus disrupting member comprising an elongatedmember having a proximal portion and a distal portion and an expandablecage; distally advancing the thrombus disrupting member into a thrombus;actuating the thrombus disrupting member to aid in the disruption of thethrombus; and drawing portions of the thrombus into the thrombectomycatheter.
 2. The method of claim 1, wherein distally advancing thethrombus disrupting member comprises advancing the thrombus disruptingmember distally beyond a distal end of the catheter body.
 3. The methodof claim 1, wherein actuating the thrombus disrupting member comprisesrepeatedly distally advancing and proximally retracting the thrombusdisrupting member.
 4. The method of claim 1, wherein actuating thethrombus disrupting member comprises proximally retracting theexpandable cage.
 5. The method of claim 1, wherein the expandable cageis self-expanding.
 6. The method of claim 1, wherein the thrombusdisrupting member further comprises an actuation mechanism, theactuation mechanism configured to move the expandable cage between acollapsed configuration and an expanded configuration.
 7. The method ofclaim 1, wherein the expandable cage comprises a plurality of wovenfilaments.
 8. The method of claim 1, wherein proximal retraction of theelongated member is configured to expand the expandable cage.
 9. Amethod of treating thrombus in a blood vessel, the method comprising:advancing a thrombectomy catheter through a blood vessel to a targetlocation, the thrombectomy catheter comprising: a catheter bodyextending from a proximal portion to a distal portion and including acatheter lumen extending between the proximal portion and the distalportion; and a thrombus disrupting member disposed within the catheterlumen, the thrombus disrupting member comprising an elongated memberhaving a proximal portion and a distal portion and an expandable cagecomprising a plurality of woven filaments and configured to move betweena collapsed configuration and an expanded configuration; distallyadvancing the thrombus disrupting member into a thrombus adjacent to thetarget location; expanding the expandable cage; and actuating thethrombus disrupting member to aid in the disruption of the thrombus. 10.The method of claim 9, wherein distally advancing the thrombusdisrupting member comprises advancing the thrombus disrupting memberdistally beyond a distal end of the catheter body.
 11. The method ofclaim 9, wherein actuating the thrombus disrupting member comprisesrepeatedly distally advancing and proximally retracting the thrombusdisrupting member.
 12. The method of claim 9, wherein actuating thethrombus disrupting member comprises proximally retracting theexpandable cage.
 13. The method of claim 9, wherein the thrombusdisrupting member further comprises an actuation mechanism, theactuation mechanism configured to move the expandable cage between thecollapsed configuration and the expanded configuration.
 14. The methodof claim 9, wherein proximal retraction of the elongated member isconfigured to move the expandable cage into the expanded configuration.15. The method of claim 9, wherein a cross-sectional diameter of theexpandable cage in the expanded configuration is larger than across-sectional diameter of the expandable cage in the collapsedconfiguration.
 16. A thrombectomy catheter, comprising: a catheter bodyextending from a proximal portion to a distal portion and including acatheter lumen extending between the proximal portion and the distalportion; and a thrombus disruption member disposed within the catheterlumen, the thrombus disruption member comprising: an elongated memberhaving a proximal portion and a distal portion; an expandable cageconfigured to move between a collapsed configuration and an expandedconfiguration; an actuation mechanism configured to move the expandablecage between the collapsed configuration and the expanded configuration.17. The thrombectomy catheter of claim 16, wherein the expandable cagecomprises a plurality of woven filaments.
 18. The thrombectomy catheterof claim 16, wherein the expandable cage comprises a plurality oflongitudinally extending struts.
 19. The thrombectomy catheter of claim18, wherein each strut of the plurality of longitudinally extendingstruts comprises a plurality of strands.
 20. The thrombectomy catheterof claim 16, wherein the thrombus disruption member is slidably and/orrotationally disposed within the catheter lumen.